Young 2020.

Study characteristics
Methods	Design: cluster‐randomised controlled feasibility trial Date of study: August 2014‐Feb 2015 Power calculation: no Inclusion criteria: patients were eligible for trial recruitment if they were aged over 65 years and admitted to the study wards during the study period. Exclusion criteria: patients were excluded if delirium was present on admission to the ward, discharge was planned within 48 hours of admission, delirium assessment had not been performed by an RA within 24 hours of admission (older people’s care patients) or preoperatively (orthopaedic trauma patients), consent had not been obtained with 48 hours of admission to the ward, end of life care was being provided or the patient was under the care of another ward.
Participants	Sample size: 713 Country: UK Setting: hospital wards ‐ orthopaedic trauma and older people care wards.  Imbalance in clinical setting between intervention and control group – 62% in intervention group in Older People’s wards and 38% in Orthopaedic Trauma compared to 49% and 51% of those in the control group. Age: 82.5 (7.9) in intervention group, 83.0 (7.8) in intervention group Sex: males, 112 (23.7) in intervention group, males, 114 (31.8) in control group Co‐morbidity: no clinically significant difference between groups for overall comorbidities. Comorbidities 236 (68.8) in intervention group 244 (65.9) in control group; Mean (SD) Charlson comorbidity index score 1.7 (2.0) in intervention group, 1.7 (1.9) in control group Dementia: cognitive impairment and/or dementia 83 (24.2) in intervention group, 67 (18.1) in control group Frailty: not reported
Interventions	Intervention: prevention of delirium programme – manualised, multicomponent intervention and systematic implementation process designed to secure ward practice changes, potentially enhanced by the involvement of hospital volunteers. Comprises of actions directly affected to optimise nutrition & hydration, reduce environmental threats, increase orientation to time and place, improve communicative practices, supporting/encouraging mobility and better management of pain and infection. Implementation is supported through raising awareness and training of staff. Control: Usual care
Outcomes	Outcomes reported: ‐ Incident delirium using CAM ‐ Inpatient mortality (within 10 days) ‐ Mortality (overall) ‐ Peak severity of delirium ( mean severity of delirium episode and mean severity of delirium at 30 days) ‐ Length of stay ‐ ADL function using NEADL at 3 months ‐ Withdrawals (not explicitly included as an outcome but reported) ‐ New care home admission at discharge ‐ Falls Outcomes from study not reported: ‐ Quality of Life using EuroQoL EQ‐5D Frequency of outcomes assessment: daily up to 10 days from admission, discharge, 30 days and 3 months
Notes	Funding source: National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (grant RP‐PG‐0108‐10037). Declarations of interest: no conflicts to declare Delirium excluded at enrolment using CAM
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation stratified by ward type in a two‐stage process, randomised 1:1 between site‐level allocation and ward level allocation. Those selected for site‐level allocation further randomised 1:1 for their wards to receive intervention or control. Those selected for ward‐level allocation randomised 1:1 for intervention or control.
Allocation concealment (selection bias)	Low risk	Performed centrally by the statistician at the Clinical Trials Unit.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were unblinded due to nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessment conducted by research assistants not involved in intervention development or delivery, but unblinded to treatment allocation. Post‐discharge outcomes were blind to allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Follow‐up at day 10 is comparable between groups. Longer term (30 day and 3 months) follow‐up affected by missing questionnaire data and deaths.
Selective reporting (reporting bias)	Low risk	Study reported as per published protocol (Trials)
Other bias	Low risk	No evidence of recruitment bias. Baseline imbalance in study populations (orthopaedic versus older adult wards) between intervention and control noted by reviewers and authors of the study. Not thought to relate to underlying bias associated with randomisation. No loss of clusters reported. Statistical analysis performed to take account of cluster design including calculation of the intracluster correlation coefficient using the incidence of new‐onset delirium expressed as a proportion of the recruited study population

ADL: activities of daily living;BMI: body mass index; CAM: Confusion Assessment Method;CAM‐ICU: Confusion Assessment Method for Intensive Care Unit; COPD: chronic obstructive pulmonary disease; CPAP: continuous positive airway pressure;CVD: cardiovascular disease; DOSS: Delirium. Observation Screening) Scale; DRS‐R‐98: Delirium Rating Scale Revised 98; DSI: Delirium Symptom Interview;DSM: Diagnostic and Statistical Manual; ENT: ear nose and throat;Hb: haemoglobin; IQR: interquartile range;IV: intravascular; MDAS: Memorial Delirium Assessment Scale; mHELP: modified Hospital Elder Life Program; MMSE: Mini Mental State Examination; Nu_DESC: Nurses Delirium Screening Scale; PVD: peripheral vascular disease; SD: standard deviation; RCT: randomised controlled trial; TIA: transient Ischaemic attack.